In a major breakthrough for rhodesiense human African trypanosomiasis (r-HAT) treatment, in August 2024 WHO recommended fexinidazole to replace suramin and melarsoprol as the first-line treatment for r-HAT, the acute form of this fatal disease.
On 30 January 2025, the World Health Organization delivered fexinidazole to the health authorities of Malawi and Zimbabwe, marking a major milestone in HAT therapy. Suramin had been introduced in 1920 to treat first-stage r-HAT, and melarsoprol had been introduced in 1949 to treat second-stage r-HAT, which was previously untreatable. Notably, although many lives were saved with melarsoprol, it also provoked a high rate of serious adverse reactions, associated with over 8% fatality. Fexinidazole simplifies the management of the disease because it is effective in both first and second stage of r-HAT; as a result, in most cases a lumbar puncture to determine disease stage is no longer necessary.
WHO/Malawi. The Hon. Minister of Health of Malawi, Dr Khumbize Kandodo Chiponda.
Prior to supplying fexinidazole, in 2024 WHO carried out training of medical staff to ensure the correct implementation of this new product and set up an active pharmacovigilance programme during the initial years of use.
After 76 years without therapeutic innovation for this neglected disease, a new and better medicine became available for patients. WHO played a key role in driving research and development for new medicines and accelerating their introduction.
Rhodesiense human African trypanosomiasis, caused by Trypanosoma brucei rhodesiense, is endemic in 13 countries across eastern and southern Africa. This acute form of sleeping sickness progresses rapidly and, if untreated, can be fatal.
In the past 5 years, T. b. rhodesiense accounted for approximately 8% of all reported human African trypanosomiasis cases. The majority of cases are attributed to T. b. gambiense, which is responsible for about 92% of reported cases.
Fexinidazole is donated by the manufacturer Sanofi to WHO in sufficient quantities to treat all patients worldwide.
